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January 8, 2007

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Integrity in Science Watch

Week of 01/08/2007

Industry Funds Sweeten Outcomes of Beverage Studies

Researchers at Children's Hospital in Boston in collaboration with the Center for Science in the Public Interest have found that researchers funded by the beverage industry are much more likely to come up with favorable results than researchers without industry funding. The study, released to the media today by PLoS Medicine, reviewed 111 studies on soft drinks, juice and milk that appeared in the nutrition literature over a five-year period. Among the 22 studies clearly identified as funded by companies or industry groups, just three (13.6 percent) came up with unfavorable findings. Among the 52 studies without industry support, 20 (or 38.5 percent) came up with unfavorable findings. The 16 industry-funded studies that intervened in the beverage choices given subjects never came up with a negative result, the study found, while 7 of 19 intervention studies not funded by industry did not find beneficial health outcomes. The study "raises serious concerns that some food industries may distort the scientific record on diet and health," wrote Martijn B. Katan, professor of nutrition at Vrije Universiteit in Amsterdam, in an accompanying perspective. It "threatens public confidence in nutrition research, and once that confidence is gone nutrition research becomes irrelevant."

Industry-Funded Scientists Answer Call on Cell Phones

A new study analyzing research on the biologic effects of cell phone use found that industry-funded studies were far less likely to identify negative consequences than studies funded by governments and non-profits. The European researchers, writing in Environmental Health Perspectives, analyzed 57 studies that appeared in the academic literature between 1995 and 2005. Only a third of those that were industry-funded (4 of 12) identified a biologic effect with possible health consequences from exposure to cell phone radio waves. On the other hand, 9 of 11 studies funded by the public or charities found such effects, while 17 of 22 whose funding source was not identified also found biologic effects. While nearly half the journals had conflict of interest disclosure policies, none of the peer-reviewed articles revealed conflicts for authors. "The interpretation of the results from existing and future studies of the health effects of radiofrequency radiation should take sponsorship into account," the study, conducted by researchers at the University of Berne and the University of Basle in Switzerland and the University of Bristol in the United Kingdom, concluded.

NEJM Finally Prints Perspective, But Removes Conflict-of-Interest Angle

The Wall Street Journal (subscription required) reported late last month that the New England Journal of Medicine had failed to print a Perspective article by its own national correspondent that analyzed the increase in dialysis patient deaths that came from overuse of Amgen’s anti-anemia drug, Epogen (erythropoietin). Robert Steinbrook's original article also criticized guidelines written by the National Kidney Foundation (NKF). The spiked article, which eventually ran on December 23 in the Lancet (subscription required), reported that NKF received 57 percent of its $19.7 million annual budget in 2005 from various corporate sponsors, including $4.1 million from Amgen and $3.6 million from Johnson & Johnson's Ortho Biotech division, both of which sell erythropoietin. It also reported that Amgen financially supported the development of the NKF-sponsored anemia guidelines, and that two-thirds of the 18 members on the guideline-writing committee disclosed financial associations with Amgen or other erythropoietin manufacturers.

Last week, NEJM ran a truncated version (subscription required) of the Steinbrook article. It focused almost exclusively on the role of Medicare payment policy in boosting erythropoietin usage among dialysis patients. It did not mention Amgen's role in lobbying Medicare to establish that policy, nor did it contain Steinbrook's reporting on the National Kidney Foundation's financial relationships with Amgen and J&J and the conflicts-of-interest on the guidelines writing committee.

NIH Meeting on Neonatal Herpes Dominated by Glaxo’s Hired Hands

The National Institute of Allergy and Infectious Diseases' upcoming meeting on neonatal herpes will showcase the views of four physicians with financial ties to GlaxoSmithKline and the industry-funded American Herpes Foundation. The goal of the Feb. 21 conference is to write clinical practice guidelines for preventing neonatal transmission of genital herpes, an extremely rare event. In mid-December, the Wall Street Journal ran a front page story describing how GlaxoSmithKline, which makes the anti-herpes medication Valtrex (valacyclovir), has funded researchers and continuing medication seminars to promote universal herpes testing among pregnant women, which could lead to significantly higher drug sales.

Of the five presenters listed in the call for the meeting, Anna Wald of the University of Washington has received grants and research support from Glaxo and Roche, and received honoraria from Novartis, all of which make antiviral drugs for herpes; Zane Brown of the University of Washington gives "two to three lectures a week advocating universal herpes testing for pregnant women, earning $1,000 to $2,500 per talk" from Glaxo, according to the Journal article; Laura Riley of Brigham and Women's Hospital is secretary/treasurer of the American Herpes Foundation, a "patient advocacy" non-profit whose board contains no patients and whose $183,000 budget in 2004 was almost entirely funded by Glaxo and Roche; and Richard Whitley of the University of Alabama at Birmingham, who will lead the final session of the day on guideline writing. Whitley serves on the speakers bureaus for Glaxo and Novartis; he also serves on the board and receives stock options and compensation from the start-up firm Fermavir, which is developing next-generation drugs aimed at the herpes family of viruses. Dr. Whitley carried out these private sector activities while running NIAID's "Collaborative Antiviral Study Group," which received over $16 million in government grants in FY2004-05 to run clinical trials. An Integrity in Science project investigation did not turn up any industry ties for the fifth presenter, David Kimberlin of the University of Alabama at Birmingham. The letter inviting physicians to attend the meeting did not contain conflict-of-interest disclosure information for any of the presenters.

Odds and Ends

The Henry Ford Health System in Detroit will prohibit drug industry sales representatives from offering free gifts, lunches or other perks to its physicians. The detailers must also schedule appointments and pay a $100 certification fee before visiting.